NCT05635201

Changes in Autonomic Nervous Activity and Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

Effects of Changes in Autonomic Nervous Activity on Changes in Blood Pressure After Anesthesia Induction: Remimazolam Versus Propofol

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Daegu Catholic University Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the effects of changes in autonomic nervous activity on changes in blood pressure after anesthesia induction between propofol and remimazolam in patients undergoing low-risk surgery. The main questions it aims to answer are: * Does remimazolam shift sympathovagal balance toward parasympathetic predominance less than propofol? * Does the less shift in sympathovagal balance toward parasympathetic predominance attenuate the reduction in blood pressure? Participants will be administered either propofol or remimazolam for anesthesia induction, after which the autonomic nervous activity and blood pressure will be measured. Researchers will compare the propofol and remimazolam groups to see if remimazolam causes less shift in sympathovagal balance toward parasympathetic predominance and subsequently attenuates the reduction in blood pressure.

Conditions

• General Anesthetics

Interventions

Type	Name	Description
DRUG	Anesthesia induction with propofol	After a 10-minute-long acclimation, general anesthesia is induced with 2% propofol at the effect-site concentration of 4 μg/ml based on the Marsh Pharmacokinetic model. The effect-site concentration was maintained at 4 μg/ml until the trachea was intubated. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentrations of propofol and remifentanil were decreased to 3 μg/ml and 0 ng/ml, respectively, until the surgical incision was made.
DRUG	Anesthesia induction with remimazolam	After a 10-minute-long acclimation, general anesthesia is induced with a 2-minute-long infusion of remimazolam at a rate of 12 mg/kg/hr, after which the infusion rate was reduced to 1 mg/kg/hr and was maintained until the surgical incision was made. Five minutes after the anesthesia induction, remifentanil was administered at the effect-site concentration of 4 ng/ml based on the Minto pharmacokinetic model until the trachea was intubated. With the initiation of remifentanil infusion, 1 mg/kg of rocuronium was administered following the calibration of the neuromuscular monitoring device. With the train-of-four count of 0, the trachea was intubated. Then, the effect-site concentration of remifentanil was decreased to 0 ng/ml until the surgical incision was made.

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-12-02
• Last updated: 2023-10-03

Locations

1 site across 1 country: South Korea